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MUSE

NDA

ALPROSTADIL | N020700 | VIATRIS SPECIALTY LLC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs3 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

CAYMAN PHARMA SROALPROSTADIL

DMF 96881992

EUROAPI HUNGARY LTDALPROSTADIL

DMF 109481994

EVERLIGHT CHEMICAL INDUSTRIAL CORPALPROSTADIL

DMF 212332008

MARUISHI PHARMACEUTICAL CO LTDALPROSTADIL ALFADEX

DMF 271302013

TIEN (TIANJIN) PHARMACEUTICAL CO LTDALPROSTADIL

DMF 342392020

EUROAPI HUNGARY LTDALPROSTADIL ALFADEX

DMF 432462025

ONO PHARMACEUTICAL CO LTDInactiveALPROSTADIL ALFADEX I.V.

DMF 104151993

NISSAN CHEMICAL INDUSTRIES LTDInactiveALPROSTADIL

DMF 118451996

CASCADE BIOCHEMICAL LTDInactiveALPROSTADIL

DMF 125691997

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 20, 2024	SUPPL -32	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 0.125MG

RLD

0 patents0 exclusivities▴

SUPPOSITORY;URETHRAL | Approved: Nov 19, 1996

No patent or exclusivity listings for this strength.

#002 — 0.25MG

RLD

0 patents0 exclusivities▾

SUPPOSITORY;URETHRAL | Approved: Nov 19, 1996

#003 — 0.5MG

RLD

0 patents0 exclusivities▾

SUPPOSITORY;URETHRAL | Approved: Nov 19, 1996

#004 — 1MG

RLD

0 patents0 exclusivities▾

SUPPOSITORY;URETHRAL | Approved: Nov 19, 1996